Application 091116

Type: ANDA
Sponsor: JUBILANT GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	TABLET, CHEWABLE;ORAL	5MG	No	No
002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	TABLET, CHEWABLE;ORAL	10MG	No	No
003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	TABLET, CHEWABLE;ORAL	5MG	No	No
004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	TABLET, CHEWABLE;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2015-02-19
A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2015-02-19
A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	5MG	TABLET, CHEWABLE / ORAL	2015-02-19
A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	CETIRIZINE HYDROCHLORIDE	10MG	TABLET, CHEWABLE / ORAL	2015-02-19

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091116-001	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091116-002	CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091116-003	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	5MG	TABLET, CHEWABLE / ORAL	2015-02-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091116-004	CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF	10MG	TABLET, CHEWABLE / ORAL	2015-02-19	`5bbf6a4d5a75…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 14 · 267 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Allergy Relief	CETIRIZINE HYDROCHLORIDE	LIDL US LLC	e5fd935d-5b60-7270-e053-2995a90a7141	2026-09-09	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
all day allergy	CETIRIZINE HYDROCHLORIDE	Rite Aid Corporation	bcbb9f5a-10b6-4a5e-a237-d29693d78103	2026-09-04	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	BAJAJ MEDICAL, LLC	36b24a3c-6284-5a6d-e063-6394a90a7743	2026-08-26	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE	CETIRIZINE HYDROCHLORIDE	BAJAJ MEDICAL, LLC	36b6d0e4-8da5-9df5-e063-6294a90af326	2026-08-26	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	17e93c22-1ff7-4af9-bd5a-448836aec65f	2026-08-25	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Childrens Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	cd895177-3c25-4a1b-81a0-b85f4877787a	2026-08-25	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride	CETIRIZINE HYDROCHLORIDE	Strides Pharma, Inc.	29c433eb-6cf4-4bcf-8b2a-0398fb4cdcba	2026-08-24	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec Allergy Cetirizine HCl	CETIRIZINE HYDROCHLORIDE	Jones Healthcare Group - Packaging Services, Inc	59cf7672-fdde-ddbd-e063-6394a90a223b	2026-08-24	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Better Living Brands, LLC	f7e16d96-4f23-cbca-e053-6394a90aef4e	2026-08-24	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
GOOD REMEDIES All Day Allergy Relief	CETIRIZINE HYDROCHLORIDE	Strive Pharmaceuticals Inc.	44410d76-5940-4611-be45-579e2db8a65d	2026-08-24	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	NuCare Pharmaceuticals, Inc.	4913192a-7364-3f19-e054-00144ff8d46c	2026-08-20	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Zyrtec Allergy Cetirizine HCl	CETIRIZINE HYDROCHLORIDE	Jones Healthcare Group - Packaging Services, Inc	59cef432-41ac-768c-e063-6294a90a38fa	2026-08-19	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
allergy relief	CETIRIZINE HYDROCHLORIDE	Walgreen Company	678dcc09-55da-4d9d-a39a-c450c61c387b	2026-08-18	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
AMAZON BASICS ALL DAY ALLERGY RELIEF	CETIRIZINE HYDROCHLORIDE	Amazon.com Services LLC	52163488-0b56-529d-e063-6294a90afc62	2026-08-17	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
QUZYTTIR	CETIRIZINE HYDROCHLORIDE	ESTEVE PHARMACEUTICALS, S.A.	573770f6-b76e-f6ba-e063-6294a90aa54d	2026-08-13	Warnings, Adverse reactions	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	LIDL US LLC	bcbbcb24-2a58-917a-e053-2a95a90af9a9	2026-08-07	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
equate allergy relief	CETIRIZINE HYDROCHLORIDE	Wal-Mart Stores Inc	b33eb97f-5ac3-4eb7-b23a-cf550ce46287	2026-08-05	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Allergy)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	3cf969e6-6bc9-4dae-ab6a-b24c0fc46b25	2026-08-03	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride (Hives Relief)	CETIRIZINE HYDROCHLORIDE	Aurohealth LLC	2b9ac0cd-9dd1-4f78-a16d-9d40f5091c0a	2026-08-03	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE
Cetirizine Hydrochloride	CETIRIZINE HYDROCHLORIDE	Cardinal Health 107, LLC	0b0190c7-acfd-4140-bcaf-9fe835ebaf49	2026-07-30	Warnings	Name fallback generic name: CETIRIZINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59746-285	cetirizine hydrochloride	cetirizine hydrochloride	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-285	cetirizine hydrochloride	cetirizine hydrochloride	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-285	cetirizine hydrochloride	cetirizine hydrochloride	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-285	cetirizine hydrochloride	cetirizine hydrochloride	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-285	cetirizine hydrochloride	cetirizine hydrochloride	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-286	cetirizine hydrochloride	cetirizine hydrochloride	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-286	cetirizine hydrochloride	cetirizine hydrochloride	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-286	cetirizine hydrochloride	cetirizine hydrochloride	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-286	cetirizine hydrochloride	cetirizine hydrochloride	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-286	cetirizine hydrochloride	cetirizine hydrochloride	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current